On November 10, the Food and Drug Administration announced it will remove the black box warning applied to estrogen-containing products since 2002. As the head of the FDA declared, “After 23 years of dogma, the FDA is going to stop the fear machine.” Finally, the agency is listening to patients and their providers.
As an OB-GYN in practice for over 20 years, I welcome this long-overdue decision.
When women go through menopause — whether surgically or naturally as ovarian function declines — they lose hormones such as estradiol, progesterone, and testosterone. The average age of menopause in the United States is 51–52, and as we live longer, women are spending nearly half their lives in this state of hormonal deficiency.
Before 2002, many women used estrogen-containing products for menopausal symptoms, supported by decades of data suggesting multiple benefits, even potential cardiovascular protection. To explore these effects further, the National Institutes of Health launched one of the largest studies ever conducted on women’s health: the Women’s Health Initiative (WHI).
This ambitious trial sought to evaluate long-term outcomes such as heart disease and cancer. To reach its large sample size, the study included women aged 50 to 79, many of whom were far beyond the menopausal transition. Crucially, the study excluded women with bothersome menopausal symptoms — those most likely to seek hormone therapy in real life.
When early results emerged, data from all participants — regardless of age, years since menopause, or hormone type — were analyzed together. The initial findings suggested a possible rise in breast cancer risk, though the results did not reach statistical significance. Nonetheless, the media quickly seized on the story, publishing alarming headlines that estrogen “causes breast cancer.” Overnight, millions of women stopped their hormone therapy, and prescriptions plummeted.
Physicians and researchers had not yet reviewed the full data before the public panic set in. What followed was two decades of unnecessary suffering. Women who could have benefited from hormone therapy were instead left untreated, often warned by well-meaning but misinformed providers.
Since then, the medical community has revisited the WHI data with a critical lens. Subgroup analyses revealed that most cardiovascular risks were seen in women who began hormone therapy more than 10 years after menopause — not in those who started early. In fact, women who initiate therapy within 10 years of menopause experience significant benefits, including improved longevity.
Further analysis shows that the modest increase in breast cancer risk is linked primarily to synthetic progestins, not estrogen itself. Women using estrogen alone — such as those without a uterus — actually showed a lower risk of breast cancer compared to non-users. Meanwhile, we’ve confirmed that estrogen remains the most effective therapy for preventing osteoporosis and improving quality of life.
Since opening my gynecology practice in Santa Barbara, I’ve made it a personal mission to correct decades of misinformation. I’ve pursued additional training in menopause and sexual medicine to ensure I can provide evidence-based, compassionate care. Every day, I meet women suffering from symptoms that are dismissed or minimized. Every day, I witness how properly prescribed hormones transform their lives — restoring energy, mood, sleep, sexual function, and bone health.
For 20 years, the medical community has failed women at this stage of life, often out of misplaced fear rather than science. The FDA’s removal of the black box warning marks an essential step toward rebuilding trust and restoring evidence-based care.
It’s time to move past outdated dogma and give women the treatment they deserve.
Dr. Maryam Guiahi is a double-board certified gynecologist who opened her practice in Santa Barbara in 2024 (http://www.fancyladydoc.com).
